Recall on Clinical Glucose Test Strips - Do Consumers Get The Same Attention?

FDA announced a recall of glucose test strip used in clinical settings. The recall in part says,"..because they may report falsely low blood glucose levels. Because the test strips are reporting falsely low blood glucose when the true levels are above 265 mg/dL, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome in a timely manner and fail to treat elevated blood glucose levels."

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm483792.htm

So if you own a clinical machine, you should take precautions and check you test strip lots.

What we don't know is are the machines and strips used by millions every day working as approved. Who know? How would we know? Ther is no proactive, ongoing post-market process that acquires test strips the way PWD do; you know from retail channels and test them.

The vast majority of comments to FDA on the proposed glucose meter guidance in 2014 called for robust post-market processes. Procedures have been written but when will they be used?

People living work a day lives run the same risk of falsely low or high glucose levels that clinical machines present. More so if the number of blood checks done on retail machines vs. clinical ones is factored in.

Shouldn we be safe with home use devices?

Another Non-invasive BG Meter?

Stumbled across this yesterday. I'd heard rumours of this new non-invasive BG monitor a while back, but it looks like they are gradually creeping towards a finished product.

It's not a continuous monitor (so can't offer trend arrows on the device or any kind of automatic alerts) but *is* measuring blood glucose values so, perhaps, might be sufficient for DVLA. Measurements look to take 10s and are made by passing radio waves through thin areas of skin such as your ear lobe, or more likely that stretchy bit between your thumb and fingers.

Results are displayed on the device and can be blue-toothily uploaded via a smartphone/tablet app to a cloud-based software platform. The app promises to use the uploaded data "to calculate and forecast immediate trends in your blood glucose levels, allowing you to adjust your food or medication intake according to your activities or how you are feeling". Sounds promising, but a bit wishy-washy and vague in terms of what that might actually *mean*.

The non-invasive nature means, of course, that you could monitor your BG many more times a day without burning through strips. Ideal when waiting for BGs to come up (or start dropping) and allowing some of those 'sugar surfing' techniques (is it just me whose toes curl every time I hear that phrase?). Also pretty handy for testing on-the-go in situations where fiddling with strips and lancets is impossible, much like Abbott's Libre.

Currently in clinical trials and the website suggests it may be available for pre-order (whatever timescale that means!) at some point in 2016

Another to go on my long list of possible 'ones to watch'.

More details at www.gluco-wise.com/

Disclaimer. I have no relationship with the manufacturers of this device and I've not been paid to write this post or publicise the product in any way.

New Clinic vs Old Clinic - Guest Post by Lucy.

After the excitement of Saturday's #t1talk and with the kind permission of someone I have only ever met 'electronically' on a forum, I am posting this account of a patient experience in clinic. For someone who has really struggled in the past, this new patient-centred approach has been nothing short of mind blowing:

"I honestly left feeling quite stunned and shocked, and with the thought "have i just walked out of some parallel universe?". It was a wonderful example of how things should be, and did wonders for my confidence in ability to communicate my own thoughts and feelings at appointments, something I've previously struggled with a lot." Lucy.

Well, as some of you may know I've been asking for a couple of years at least to switch from one local hospital to the other, due to not being happy with the way I'm treated at the hospital I had been going to. After my last appointment there, I was so surprised and upset at what happened that I went and saw my GP, explained how I felt whilst holding back the tears, and he asked me to write a letter to the consultant explaining what happened from my point of view. I'm not one for complaining but for the first time, as instructed, I wrote a 2 page letter explaining where things went wrong, asking for further explanations of the decisions I disagreed with, and backing up my point of view with evidence from official bodies.

So it was very exciting this week to have my first appointment at the other hospital. There was a bit of mix up with the appointment letters going to the wrong address so it was all a bit sudden but I got there. I don't want to name the hospitals, as I'm sure others have good experiences at the other hospital, but some of you will know where I mean.

Usually I leave appointments and start crying. I left this appointment feeling like I'd left a parallel universe.

My appt started promptly and lasted over half an hour. The nurse introduced themself and told me their name and role etc.

It is a very nurse led clinic. There are consultants too, but she explained that the nurses focus just on analysing patterns in BGs etc day to day, and that makes them pretty strong at that, whilst the consultants see the bigger picture - they're important too they just have different roles.

I was asked my opinion a lot. Am I happy with my diabetes control. Any thing I want to change or improve?

I was talked to like a competent and knowledgeable adult. My opinions werent just asked for but they were listened to and responded to.

The attitude was that I am a key part of decisions and I should steer things. It was about letting me know what they can offer me, and leaving it to me to decide what I want. If I want to see a dietician I can, if I want to see the DSN very often or very little, then we can arrange that too. If I want to communicate via phone or email, then I can do that too. Wrote down the details for me.

I was offered carb counting courses for the first time, in groups or one to one. It wasn't a "you should do this" it was a "you should know we can do this, if it's something you decide you want to do at any point".

Insulin pumps were brought up by them not me. There are several hundred people on NHS funded insulin pumps at the clinic and they are not all T1. I was told not being [classic] T1 doesn't mean pumps aren't an option, though it is more rare. They also made sure my expectations were realistic and that I didn't take it to mean "of course you can definitely have a pump".

I was asked how I find Tresiba, how do I think it's working and how do I find it. I've told previous Drs that I dont think it gives me a benefit over levemir/lantus and been told, "Yes it does, its very good, stay with it". I told the nurse that I don't think it is worth the extra cost and instead of telling me I'm wrong, she asked why and I explained. Basically we had a normal adult conversation like normal adults do rather than one person treating the other like a child.

I was asked if I'd tried the tablet that makes you pee out sugar (can't remember the name). That was mentioned as an option I hadn't tried, and that I can try it with insulin. I wasn't told "you should try this", I was told "this is what it does and how it works and the benefits of it" so that I could think about it as an option that hadn't been mentioned before.

I was asked if there is a particular consultant I wanted to see or if I'm happy to see any. I was interested in seeing one that knows about pumps but of course they're all pretty pump knowledgable anyway.

One tweak was suggested to me to experiment with, which is to try a bolus as soon as I wake up, before getting out of bed even, to stop the DP (dawn phenomenon). I was nervous about trying it because of having insulin when walking the dog, but felt comfortable with trying it - starting small - after chatting it over.

They showed interest in my Libre sensor, had heard of it, and were interested in how I found it and how it improved my life. They looked at the weeks daily BG traces I had printed off and saw patterns and generally seemed interested in the data. It must be years since anyone has even looked at the BG printouts I take and offer them. I'd been told sensor is a waste of money and not to use it at my previous clinic.

My A1c is 68, at last hospital I had been told "well that's close to target of 8% so stop the apidra now". When I kept saying my personal target is under 6.5%, I was told to be realistic and that that isn't possible without loads of hypos. At the new hospital I was listened to when I said I wanted it lower to reduce risk of complications, as I have plans for a long healthy life. Only opinion given on my BGs was that whilst they could be lower they aren't terrible, but if I want to improve them then we can work together on that.

I was asked when/if I wanted to come back to see the DSN again. It could be as soon or far away as I liked really, it was up to me. I was a bit surprised by all this 'being asked what I wanted' to be honest and didn't know what to say, so she suggested a time period and I agreed to that.

I've said or thought previously that in an ideal world, my diabetes appointments would be like my one-to-ones with my boss. He asks me what I'm happy with and where I want to improve, if there are any courses I think would help me, or any support that I feel I need. He asks what targets I want to set and where I want to get to. He offers some feedback, guidance and suggestions, but it's a two way conversation, between two competent adults. My previous diabetes appointments have never been like this. My new one was like that.

I honestly left feeling quite stunned and shocked, and with the thought, "Have i just walked out of some parallel universe?". It was a wonderful example of how things should be, and did wonders for my confidence in ability to communicate my own thoughts and feelings at appointments, something I've previously struggled with a lot.

Thank you so much for sharing this Lucy. Sounds pretty much perfect.

#talkt1 - Brainstorming a new model of care for T1 diabetes

Bright and early on Saturday morning I caught the train to sunny Southampton where I had been invited to attend '#talkt1', and event organised by everyone's second-favourite rabble-rousing diabetologist and all-round live wire Partha Kar. It was a real honour to have been invited and the attendees to the event were an extraordinary who's who of passionate, committed T1 specialists, consultants and paediatrics, commissioners, DSNs, plus various NHS big-wigs such as Jonathan Valabhji and Diabetes UK's CEO, Chris Askew.

The majority of the party had gathered the evening before, for some presentations, talk of Vanguards and 5 year forward and time to think and talk together. This was not some back-slapping jolly though. These amazing people had given up their weekends to take a tough look at how type 1 diabetes care is delivered in the UK and to see if they couldn't begin to rethink it. One chilling statistic from Pratik Choudhary's presentation was recounted on Saturday morning:

‘Current practice kills at least 30% more people by the age of 50 than best practice should achieve’

Saturday morning began with some patient stories. Kev Winchcombe gave a moving account of the diagnosis of his daughter, and the huge journey they have been on ever since (yes that's right, I'm using the 'J' word - deal with it). Laura (ninjabetic) spoke of her initial struggles, lack of education (100 units a day and no instruction about balancing that with carbs!) and how connecting with others on Social Media has made such a difference to her self-care. Jens Birkenheim spoke of his frustration with not being able to find the sort of care he needed - or even where to start looking - which led him to begin setting up DCareFinder, a website that allows you to search for diabetes services near where you live. It was then my turn to talk about my experiences as a lay member of the Guideline Development Group for the NICE T1 Guidelines, how I came to be involved and whether I thought they helped me as a patient.

It was interesting to hear the same themes coming out again and again in each of these patient stories. The need for education, right from the start and as an ongoing part of living with T1D. The variety of care experiences in the UK, sometimes exceptional, other times disastrous. The value of using technology, digital-connectivity and peer-interaction as tools in our daily dance with T1.

It was then time for some thoughts from the diabetes 'legends' - Professor Simon Heller and Dr Fiona Campbell who spoke about adult and paediatric care respectively. One quote from Prof Heller particularly stood out to me. He said, "We don't often tell our patients this, but there is no condition which demands more of the individual than type 1 diabetes".

There was a lot of tough talk. A genuine sense that these people felt they could do better - and wanted to make that happen.

In the afternoon the room split into 4 'teams' each given a scenario of a hospital trust/healthcare setting and pot of cash. They were then asked to see what they could come up with (in a matter of just a few hours) as a new model of care for type 1 diabetes. "If we were starting from scratch," Partha said as he introduced the game, "I think we can all be pretty sure that we wouldn't end up where we are". Us patient-types were free to roam around from table to table and stick out oar in. Giving feedback as to whether we liked the ideas being floated. After a break for lunch, there was just enough time to draw the ideas together before they were to be presented to a guest panel of 'judges', including two CCG Commissioners and Roz Davies as a patient representative.

I'm not quite sure what Partha expected to get out of this scrap-of-time-workshop, but there were a number of very interesting ideas floating around as the 4 different models were presented. It was fascinating that no one really based their idea on needing a stack more money. Most of the thoughts were priced loosely within the specified budgets, and it seemed that these may have been thoughts that people had been musing on for some time. I didn't take any notes so can't really recount them in detail, but here are a few things which caught my attention at the time.

• The idea of 'front loading' finances. Implementing additional education and support up-front with the money that you would expect to spend later on acute admissions or complications that can be avoided.
• Identifying people who are stuggling not only by HbA1c and/or admissions, but also on their level of 'diabetes distress'
• The importance of education delivered by people specifically trained in T1D
• The potential of 'community hubs', making it easier for people to access care near where they live, as often as they need it
• The importance of psychological support - as Dr Fiona Campbell put it "Psychologists will never sit idle - so much is discovered by universal screening. You don't know what you don't know"
• The potential of technology - Skype consultations, remote/digital clinics, regular data-upload and review, email and *gasp* seamless sharing of information between GP and hospital clinics
• The huge potential of peer support as part of a new model of care
• A modular education approach - Diabetes seen as a journey through life with various milestones. People have different needs/aspirations and will be ready to access education at different times - the ability to dip in and out of primary and secondary care with varying frequency
• That people are different, and that approaches need to be tailored to better support individuals

It was a really inspiring day. You got the feeling there were some real sparks flying. That if anyone could begin to stir up the current state of T1 care in the UK, then this would be a pretty good starting line-up. It will be interesting to see what comes out of it in the coming months and years. Huge thanks and much respect to Partha Kar for his energy and commitment to improving things for us pancreatically challenged lot.

If you want other perspectives on the day you can also read blogs by Partha, Roz, Laura and Kev.

Disclaimer. Very kindly, my train ticket was paid for and the lovely Kev W gave me a lift to the venue. Lunch was laid on, but all of us patient speakers gave their time for the privilege of being involved in such an amazing day.

Reason for Blood Sugar Rise : caffeine

Your glucose can ascend after you consume coffee - even dark ones

without any calories because of the caffeine in it.



Other foods in the same categories of caffeine content like coffee are

dark tea, green tea, and

caffeinated drinks.



Every individual with

diabetes responds to sustenances and drinks in an unexpected way, so

it's best to monitor your own reactions.



However, it must be noted that other contents in coffee might offer assistance

to prevent diabetes in

healthy individuals with no diabetes.